NCT04949126

Brief Summary

To describe and understand the self-medication behaviours of a population of adults coming to the Clermont-Ferrand dentistry department for acute pain of pulpal origin and of a population of adults coming to the specific care unit of the Clermont-Ferrand dentistry department or the Riom hospital for treatment under general anaesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

April 8, 2024

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

June 18, 2021

Last Update Submit

April 5, 2024

Conditions

Dental AnxietyDental Pain

Keywords

AnxietyPulpal painSelf medicationObservational study

Outcome Measures

Primary Outcomes (1)

  • description of the self-medication behaviours

    evaluated by patient interrogation

    day 0

Secondary Outcomes (4)

  • level of anxiety

    day 0

  • level of insecurity

    day 0

  • description of the oral health with the related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF)

    day 0

  • visual analogue pain assessment scale and the PCS-CF pain dramatisation scale

    Day 0

Study Arms (2)

acute pain of pulpal origin

no intervention

Behavioral: questionnaire

anxious group

no intervention

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

questionnaires of precarity, dental anxiety, self medication, pain

acute pain of pulpal originanxious group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient with acute pain of pulp origin and periapical or eligible for dental treatment under general anesthesia in a context phobic.

You may qualify if:

  • Adult patient, male or female, coming to consult in the Clermont-Ferrand or Riom Hospital for acute pain of pulp origin and periapical OR eligible for dental treatment under general anesthesia in a context phobic.
  • Understanding and practicing French
  • giving informed consent to participate in research.
  • Affiliation to a Social Security scheme.

You may not qualify if:

  • Patients under guardianship.
  • Patient's refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

ToothacheAnxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pierre-Yves Cousson

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 2, 2021

Study Start

June 15, 2021

Primary Completion

May 12, 2023

Study Completion

May 12, 2023

Last Updated

April 8, 2024

Record last verified: 2023-06

Locations

FR(1)